A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants

NCT06589726 | Completed Phase 1

• 2 other identifiers: MS200569_00652024-512841-17-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Enpatoran

  Pre-dose on Day 1 (baseline) up to 24 hours post-dose

Secondary Outcomes (9)

• Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Moxifloxacin

  Pre-dose on Day 1 (baseline) up to 24 hours post-dose

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 72 days

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity

  Up to approximately 72 days

• Number of Participants with Abnormal Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings

  Up to approximately 72 days

• ECG Parameters: QT Interval, heart rate-corrected QT interval (QTc), individual corrected QT interval (QTcI), PR Interval, QRS interval and RR Interval

  Pre-dose up to 24 hours post-dose

Study Arms (4)

Treatment Sequence 1: A-B-C-D

EXPERIMENTAL

Participants will receive a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 1, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 2, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 3, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.

Drug: Placebo; Drug: Moxifloxacin; Drug: Enpatoran low dose; Drug: Enpatoran high dose

Treatment Sequence 2: B-D-A-C

EXPERIMENTAL

Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 1, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 2, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 3, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.

Drug: Placebo; Drug: Moxifloxacin; Drug: Enpatoran low dose; Drug: Enpatoran high dose

Treatment Sequence 3: C-A-D-B

EXPERIMENTAL

Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in treatment period 1, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 2, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 3, followed a by single oral of moxifloxacin tablet (Treatment B) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.

Drug: Placebo; Drug: Moxifloxacin; Drug: Enpatoran low dose; Drug: Enpatoran high dose

Treatment Sequence 4: D-C-B-A

EXPERIMENTAL

Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in treatment period 1, followed by a single oral low dose of enpatoran (Treatment C) in treatment period 2, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 3, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.

Drug: Placebo; Drug: Moxifloxacin; Drug: Enpatoran low dose; Drug: Enpatoran high dose

Interventions

Placebo DRUG

Participants will receive a single oral dose of placebo matched to enpatoran in either of treatment period 1, 2, 3 and 4.

Treatment Sequence 1: A-B-C-D; Treatment Sequence 2: B-D-A-C; Treatment Sequence 3: C-A-D-B; Treatment Sequence 4: D-C-B-A

Moxifloxacin DRUG

Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in either of treatment period 1, 2, 3 and 4.

Treatment Sequence 1: A-B-C-D; Treatment Sequence 2: B-D-A-C; Treatment Sequence 3: C-A-D-B; Treatment Sequence 4: D-C-B-A

Enpatoran low dose DRUG

Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in either of treatment period 1, 2, 3 and 4.

Also known as: M5049

Treatment Sequence 1: A-B-C-D; Treatment Sequence 2: B-D-A-C; Treatment Sequence 3: C-A-D-B; Treatment Sequence 4: D-C-B-A

Enpatoran high dose DRUG

Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4.

Also known as: M5049

Treatment Sequence 1: A-B-C-D; Treatment Sequence 2: B-D-A-C; Treatment Sequence 3: C-A-D-B; Treatment Sequence 4: D-C-B-A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are overtly healthy, as determined by medical evaluation, including no clinically significant abnormality identified on medical history, physical examination, vital signs, 12-lead ECG, or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
• Participants have a body weight within the range 50.0 to 100.0 kilograms (kg) (inclusive) and body mass index (BMI) within the range 19.0 to 30.0 kilograms per square meter (kg/m\^2) (inclusive)

You may not qualify if:

• History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric (due to rare risk of hallucinations, agitation, and activation of psychosis), and other diseases or disorders, and epilepsy, as determined by medical evaluation
• Individuals with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease
• Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to the first administration of study intervention
• History of malignancy (e.g. hematologic, skin, solid tumor) less than or equal to (\<=) 10 years prior to Screening
• History of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission to CRU, or hospitalization due to infection within 6 months prior to the first administration of study intervention
• History of shingles within 12 months prior to Screening

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Germany

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)